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Users must provide patients with information.
Intended use
To limit injection pressure
Indications
Prevention of excessively high intrafascicular dynamic injection pressures and
detection of cannula malposition (contact between the cannula and the nerve
wall or the cannula and the fasciae) in the context of hydrostatic opening pres-
sure during peripheral anesthesia, analgesia.

Contraindications

There are no known contraindications
Complications
There are no known complications if the device is used correctly.
If complications occur while using the device, follow the protocols of your
organisation. If this does not resolve the complications, or if they are
regarded as serious or untreatable, carefully stop the procedure and remove
invasive device components from the patient.
Warnings
for sterile product:
This is a disposable medical device for use with only one patient.
This device must not be re-used under any circumstances.
This device must not be resterilised under any circumstances.
The materials used in the manufacture of this device are not suitable for repro-
cessing or resterilisation.
This device is not designed to be reprocessed or resterilised.
Unauthorised re-use or reprocessing
• can cause the device to lose the performance properties intended by the
manufacturer.
• leads to a significant risk of cross-infection/ contamination as a result of
potentially inadequate processing methods.
• may cause the device to lose significant functional properties.
• may cause materials to break down and lead to endotoxic reactions
caused by the residues.
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